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  5. 8.4 - Laboratory Controls - OOS Investigation and Form
  • <Laboratory analyst wearing blue gloves conducting an OOS investigation by completing a phase 1 form. Credit> AdobeStock_391585993
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    147005408 © Ryzhov Sergey | Dreamstime.com
  • <Two graphs showing out of specification results for vitamin C, one for a QC batch release result, the other for two stability time points, one above specification limit and the other below. Credit> GMP-SOP-Download.com
    GMP-SOP-Download.com
  • <Two graphs showing results that are within specification but are out of trend with the other results for vitamin C, one for QC batch release testing and the other for stability time points. Credit> GMP-SOP-Download.com
    GMP-SOP-Download.com
  • <Graph showing atypical or out of trend OOT stability results where one particular batch is degrading much faster in ferrous iron than all previous batches stability tested. Credit> GMP-SOP-Download.com
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By GMP-SOP-Download Drug

8.4 - Laboratory Controls - OOS Investigation and Form

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An out of specification investigation must be completed each time a laboratory test, examination or the result of any monitoring fails to meet an established specification; one investigation per OOS test parameter. This applies to physical, chemical, & microbiological tests or examinations, stability testing, monitoring, and validation

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GMP-SOP-Download Drug8.5 - Laboratory Controls - Physical and Chemical Testing
<One half of picture pipetting clear liquid into blue glass bottles, the other half shaking a conical flask containing bright, clear amber liquid, all against a subtle background of the periodic table of elements. Credit> AdobeStock_101292718
<Bottle of capsules labelled Identity, one of the drug specification requirements, on a white table with a blurred pharmacy and pharmacist background. Credit> Freepik
GMP-SOP-Download Drug8.3 - Laboratory Specifications
<Laboratory analyst wearing blue gloves conducting an OOS investigation by completing a phase 1 form. Credit> AdobeStock_391585993
£36.99 GBP
£36.99 GBP